Industry Briefs

FDA Advisory Panels Recommend Removal of Black-Box Warning From Chantix

Pfizer announced last month that two Food and Drug Administration (FDA) advisory panels recommended that the black-box warning regarding serious neurospsychiatric events be removed from the label of the smoking cessation medication Chantix (varenicline).

The boxed warning was added to the Chantix label in 2009 after reports of patients’ experiencing suicidal thoughts and aggressive and erratic behavior while on the medication.

The recommendations for the removal of the black box warning came after Pfizer submitted new data from a randomized, blinded, placebo-controlled clinical trial conducted in collaboration with GlaxoSmithKline. That trial compared the safety and efficacy of varenicline, bupropion, and nicotine patch in more than 8,000 smokers with and without a history of psychiatric disorders. The trial revealed that people taking varenicline or bupropion did not show a significant increase in neuropsychiatric adverse events relative to nicotine patch or placebo.

FDA OKs Label Change to Rexulti, Highlighting Maintenance Treatment for Schizophrenia

The FDA has approved a labeling update to Rexulti (brexpiprazole) to reflect clinical trial data for maintenance treatment of schizophrenia, according to Otsuka Pharmaceutical Development and Commercialization Inc. and H. Lundbeck A/S, co-developers of the medication. Rexulti was first approved in July 2015 as a treatment for adults with schizophrenia and adjunctive therapy to antidepressant medication for adults with major depressive disorder.

The data showed that patients who were randomized to Rexulti had a statistically significant longer time to relapse compared with those in the placebo group. ■